Diarrhea, InfantilePE-DIANCT04209751
Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits (PE-DIA)
An observational study of Diarrhea, Infantile, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Acute diarrhea in children is a public health problem. It is estimated that children under 3 years are subject to 1 or 2 episodes of diarrhea per year in Europe. These diarrheal episodes are frequent, expensive and responsible for many consultations and hospitalizations in developed countries. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Diarrhea, Infantile
- What is being tested?
- Stool removal
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged from 0 to 16 years with diarrhea
Who may be able to join
- Children aged from 0 to 16 years with diarrhea
- pediatric emergency at the University Hospital of Clermont-Ferrand consultation
- between june and september 2020
Who cannot join
- consent not felt by the child or the person with parental authority
- no stool removal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits
Acute diarrhea in children is a public health problem. It is estimated that children under 3 years are subject to 1 or 2 episodes of diarrhea per year in Europe. These diarrheal episodes are frequent, expensive and responsible for many consultations and hospitalizations in developed countries. The origin of diarrhea in children is viral in about 70% of cases. The diagnosis of a viral infection is often considered without microbiological evidence. However, microbiological evidence is recommended for certain categories of patients.
The involvement of bacteria or parasites in the child's diarrhea does not seem negligible.
Read more
The main objective of this study is to estimate the prevalence of infectious diarrhea among summer diarrhea in children leading to pediatric emergency room visits.
Secondarily, we will describe the pathogens responsible for childhood diarrhea during the summer period, describe common factors that can serve as guidance on the etiology of diarrhea, and describe common factors that can be used as tools. preventive to the transmission of these pathogens.
Read the detailed description
After obtaining consent from the holders of parental authority, a stool collection will be requested from all pediatric emergency patients presenting as a reason for "diarrhea" consultations between June 1 and September 30, 2020. It will be given by the nurse organizing the reception, a medical information questionnaire and a stool collection container for those accompanying a child with diarrhea.
If the child presents stool during the waiting period or during the medical consultation, these will be collected and sent to the medical biology laboratory of the University Hospital for a broad analysis (virological, bacteriological and parasitological).
The doctor in charge of the patient will complete a pre-established clinical information sheet.
In the laboratory, the stool will be taken care of and a DNA extract will be made and preserved. The search for pathogens will be carried out by molecular biology, by series, non-prospectively. The results will only be transmitted at a distance and will not be communicated to families.
Therapeutic management of children included in the study will be identical to the usual practice. Microbiological analysis will not delay, prolong or disrupt the treatment of the acute episod of diarrhea.
- Conditions
- Diarrhea, Infantile
- Being tested
- Stool removal
- Keywords
- Microbiologic diagnosis, summer diarrhea, pediatric population
- Medical subject headings
- Diarrhea, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool removalDiagnostic test
Stool removal; freezing an aliquot at -20 ° C and performing a direct examination. DNA extraction and serial PCR (Polymerase chain reaction).
| Study group | Role | What they receive |
|---|---|---|
| Children with summer diarrhea | Children aged 0 to 16 years with diarrhea Receives: Diagnostic Test: Stool removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of infectious diarrhea in children who consult pediatric emergencies in summerdiarrhea leading to pediatric emergency room visits
percentage of positive stool tests (PCR (polymerase chain reaction) and direct microscopic examination)Stool sent instantly to the laboratory. Microbological research : PCR and direct microscopic examination.
Measured: Day 0
Secondary outcomes (3)
Describe pathogens found in stool
Identification of pathogens by PCR and direct microscopic examination.
Measured: Day 0
Describe common factors that can serve as preventive tools for the transmission of these pathogens.
prospective analyzes of data collected from parental authority using a questionnaire
Measured: Day 0
Describe common factors that can be used as guidance on the etiology of diarrhea
prospective analyzes of the data collected from the parental authority and causal link with a specific germ
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Jun 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diarrhea, InfantileStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Society ELITECH
- Responsible party
- Sponsor
- Investigators
- Matthieu Verdan, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209751
- Sponsor's protocol ID
- RNI 2019 VERDAN
- Other IDs
- 2019-A02341-56
- Acronym
- PE-DIA
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2019
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mallier C, Creuzet E, Lambert C, Delmas J, Mirand A, Rochette E, Valot S, Moniot M, Dalle F, Henquell C, Merlin E, Poirier P, Verdan M, Nourrisson C. Summer diarrhea in children: a monocentric French epidemiological observational study. Sci Rep. 2023 Sep 12;13(1):15078. doi: 10.1038/s41598-023-42098-x.
PubMed 37700075
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits
- ClinicalTrials.gov ID
- NCT04209751
- Acronym / sponsor ID
- PE-DIA / RNI 2019 VERDAN
- Conditions
- Diarrhea, Infantile
- Keywords
- Microbiologic diagnosis, summer diarrhea, pediatric population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Society ELITECH
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute diarrhea in children is a public health problem. It is estimated that children under 3 years are subject to 1 or 2 episodes of diarrhea per year in Europe. These diarrheal episodes are frequent, expensive and responsible for many consultations and hospitalizations in developed countries. The origin of diarrhea in children is viral in about 70% of cases. The diagnosis of a viral infection is often considered without microbiological evidence. However, microbiological evidence is recommended for certain categories of patients.
The involvement of bacteria or parasites in the child's diarrhea does not seem negligible.
The main objective of this study is to estimate the prevalence of infectious diarrhea among summer diarrhea in children leading to pediatric emergency room visits.
Secondarily, we will describe the pathogens responsible for childhood diarrhea during the summer period, describe common factors that can serve as guidance on the etiology of diarrhea, and describe common factors that can be used as tools. preventive to the transmission of these pathogens.
Detailed description
After obtaining consent from the holders of parental authority, a stool collection will be requested from all pediatric emergency patients presenting as a reason for "diarrhea" consultations between June 1 and September 30, 2020. It will be given by the nurse organizing the reception, a medical information questionnaire and a stool collection container for those accompanying a child with diarrhea.
If the child presents stool during the waiting period or during the medical consultation, these will be collected and sent to the medical biology laboratory of the University Hospital for a broad analysis (virological, bacteriological and parasitological).
The doctor in charge of the patient will complete a pre-established clinical information sheet.
In the laboratory, the stool will be taken care of and a DNA extract will be made and preserved. The search for pathogens will be carried out by molecular biology, by series, non-prospectively. The results will only be transmitted at a distance and will not be communicated to families.
Therapeutic management of children included in the study will be identical to the usual practice. Microbiological analysis will not delay, prolong or disrupt the treatment of the acute episod of diarrhea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with summer diarrhea | – | Diagnostic Test: Stool removalChildren aged 0 to 16 years with diarrhea |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged from 0 to 16 years with diarrhea
Key inclusion criteria (3 listed)
- Children aged from 0 to 16 years with diarrhea
- pediatric emergency at the University Hospital of Clermont-Ferrand consultation
- between june and september 2020
Key exclusion criteria (2 listed)
- consent not felt by the child or the person with parental authority
- no stool removal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool removalStool removal; freezing an aliquot at -20 ° C and performing a direct examination. DNA extraction and serial PCR (Polymerase chain reaction). | Diagnostic test | Children with summer diarrhea |
Primary outcome
Prevalence of infectious diarrhea in children who consult pediatric emergencies in summerdiarrhea leading to pediatric emergency room visits
Time frame: Day 0
percentage of positive stool tests (PCR (polymerase chain reaction) and direct microscopic examination)Stool sent instantly to the laboratory. Microbological research : PCR and direct microscopic examination.
3 secondary outcomes
Describe pathogens found in stool
Time frame: Day 0
Describe common factors that can serve as preventive tools for the transmission of these pathogens.
Time frame: Day 0
Describe common factors that can be used as guidance on the etiology of diarrhea
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 37700075Mallier C, Creuzet E, Lambert C, Delmas J, Mirand A, Rochette E, Valot S, Moniot M, Dalle F, Henquell C, Merlin E, Poirier P, Verdan M, Nourrisson C. Summer diarrhea in children: a monocentric French epidemiological observational study. Sci Rep. 2023 Sep 12;13(1):15078. doi: 10.1038/s41598-023-42098-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthieu Verdan principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea, Infantile, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of infectious diarrhea in children who consult pediatric emergencies in summerdiarrhea leading to pediatric emergency room visits (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04209751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.